Experts in CRA’s Life Sciences Practice evaluated the impact of delayed generic entry in a Canadian Section 8 matter involving an oral oncology product. CRA estimated the amount of sales that generic manufacturers would have made if they had been allowed to enter earlier.
CRA’s analysis included an assessment of how earlier generic entry would have impacted the total volume (brand plus generic) of molecule sales; what share of the total market generics would have captured; and what share of the generic sales individual generic manufacturers would have captured in various scenarios with different entry dates and entry order. A complicated consideration was the availability of two dosages of the product that could be used interchangeably. Each dosage had different generic entry dates, and some generic manufacturers entered with only one of the dosages. CRA’s expert analysis had to account for potential substitution across the dosages depending on the generic entry scenario.
